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NCT Number: NCT06224816

Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants

Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).

Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.

To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm < 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.

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Key information

Conditions

Premature Lungs Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

0 day–30 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location status: Recruiting

Location contact

Maria Teresa Moral Pumarega

CONTACT

[email protected]

649921733 ext. +34

About this study

Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborn prematurity
  • Age: less than 30 days of life
  • Required respiratory support with non-invasive ventilation (NIV)
  • Premature infant has not been on NIV for more than 3 days before being included in the trial.
  • Signature of the Informed Consent (IC)

Exclusion criteria

  • Failure to meet entry criteria
  • Cyanotic congenital heart disease diagnosis
  • Presence of serious malformations
  • Presence of airway malformations

Treatment and study plan

Custom 3D mask (3DM) application in neonate

Device

Premature infants with a birth weight less than 1500 g r first received 3D mask during 4 hour, then crossed over to traditional mask.

Traditional mask (TM) application in neonate

Device

Premature infants with a birth weight less than 1500 g r first received traditional mask during 4 hours, then crossed over to 3D mask.

Primary outcomes

  1. Time in which preterm maintain SatO2 below 85%.

    Time frame: 7 days

    To compare the time in which preterm maintain SatO2 below 85%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).

Secondary outcomes

  1. Time in which preterm maintain bradycardias.

    Time frame: 7 days

    To compare the time in which preterm maintain bradycardias - heart rate below 100 beats per minute - that occur in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).

  2. Time in which preterm maintain SatO2 below 75%.

    Time frame: 7 days

    To compare the time in which preterm maintain SatO2 below 75%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).

  3. Number of times requiring cardiopulmonary resuscitation

    Time frame: 7 days

    Compare the number of times requiring cardiorespiratory resuscitation with self-inflating bag in the context of apnea pause or severe desaturation in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).

  4. Appearance of cutaneous lesions in nasal region or mucosa

    Time frame: 7 days

    To compare the appearance of cutaneous lesions in the nasal region or nasal mucosa as a consequence of the pressure exerted by any of the masks, indicating the location and degree of the wound in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).

  5. Pain assessment with scoring scale.

    Time frame: 7 days

    To compare the degrees of pain, measured in the neonatal pain scale PIPP-R (Premature Infant Pain Profile-Revised), obtained every 12 hours in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM). Regarding the PIPP-R scale, the minimum score is 1 and the maximum is 21. Scores between 1-6 correspond to mild pain, 7-11 moderate pain, and 12-21 severe pain.

Study contacts

Contact information is provided by the study sponsor or research team.

María Teresa Moral Pumarega

CONTACT

[email protected]

649921733 ext. +34

Sponsors and collaborators

Lead sponsor

Hospital Universitario 12 de Octubre

Other

Collaborators

  • ISCIII

Registry information

Official study title

Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants

Acronym: M3DPREMAT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 25, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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